K812315 is an FDA 510(k) clearance for the BACTEC RESIN CULTURE MED. 16A. This device is classified as a System, Blood Culturing (Class I - General Controls, product code MDB).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 10, 1981, 85 days after receiving the submission on August 17, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K812315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1981 |
| Decision Date | November 10, 1981 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | MDB — System, Blood Culturing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2560 |